In many medical procedures, including but not limited to angiography and stent implantations, it is necessary to make an incision in an artery of the body, typically the femoral artery, to allow for access into the vasculature, of a guidewire, catheter, balloon catheter, stent, navigational wire, or the like. Once that incision is made and the medical procedure is performed, the apparatus is all withdrawn from the vasculature and the opening in the femoral artery must be repaired.
Over time many devices and methods have been developed for doing so. Conventionally, mechanical compression is simply applied using hand pressure, weighted bags or similar structure, to apply sufficient pressure to the artery until hemostasis can be achieved. While effective, the process can be relatively slow, often taking up to 24 hours for a clot to be formed. In addition, during this time, the patient must remain stationary. In addition, the simple application of such pressure or weight is often of great discomfort to the patient, or can detrimentally affect other systems of the body due to the applied weight, pressure and immobility.
In other attempts, an anchor of some form is introduced into the blood vessel to serve as a back stop against which closure gels or structures can be pushed. For example, a balloon catheter can be introduced into the blood vessel, and expanded, and thereafter retracted until the balloon engages an inside surface of the blood vessel wall. At that point, a collagen plug, foam pledget, or similar structure can be tamped down against the balloon to form a seal. While this is also effective, such devices and methods do have the unfavorable disadvantage of positioning a portion of the closure within the blood vessel itself.
In still further devices and methods, it is known to close the opening in a blood vessel wall without leaving any foreign body behind after the procedure. For example, cautery devices can be used to heat the collagen within the blood so as to form a clot. Such cautery devices can use conventional heating methods or function through the introduction of radio frequency energy between first and second electrodes positioned proximate the blood vessel wall. In other devices, ultrasonic energy can be directed to the blood vessel wall with the cells themselves being vibrated at a frequency sufficient to cause sufficient heat and hemostasis as well.
While these latter devices and methods can be effective, they are often difficult for the physician to execute, can cause pain to the patient, and can be relatively time consuming. Accordingly, it would be advantageous to provide an apparatus or method for closing the opening in the blood vessel which is immediate and relatively easy for the physician to execute, but which does so without leaving any structure behind, or at least using structure which is bioabsorbable after a relatively short period of time, thereby ultimately leaving no foreign substance in the body.